The following data is part of a premarket notification filed by Orthotec, L.l.c. with the FDA for 5.0mm Spinal Screws.
| Device ID | K994288 |
| 510k Number | K994288 |
| Device Name: | 5.0MM SPINAL SCREWS |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ORTHOTEC, L.L.C. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf ORTHOTEC, L.L.C. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-20 |
| Decision Date | 2000-04-10 |
| Summary: | summary |